A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)

A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)

The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.

To compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/SIRS.

Methods: This was a prospective controlled randomized study in 58 critically ill patients. They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.

Inclusion Criteria:

• sepsis or SIRS (APACHE score 10-30),
• no severe gastrointestinal tract or metabolic diseases,
• enteral feeding within 48 h of admission,
• age 18-75 years,
• written consent by patient or next of kin. -

Exclusion Criteria:

• participation in a drug trial within the last 4 weeks before inclusion in this study,
• previous participation in this study,
• expected patient survival of less than 6 days,
• pregnancy or lactation,
• patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation,
• severe liver disease with cytolysis (ASAT >10 N) or impaired detoxification (ammonia >50 mmol/L, bilirubin > 50 μmol/L),
• gastrointestinal surgery in the last 4 weeks,
• severe enteritis/colitis,
• short intestine syndrome,
• gastrointestinal bleeding that requires intervention,
• patients who could not be enterally fed